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Terminated

BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.

FDA Recall Z-1524-2013 · Posted 2013-06-08

Recall StatusTerminated
Product CodeFZP
Date Initiated2013-04-16
Date Terminated2014-01-30
Product Quantity3,085

Reason for Recall

Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use.

Firm Action

Bard Peripheral Vascular, Inc. initiated a recall of certain product code and lot number combinations of Bard UltraClip Dual Trigger Tissue Marker by contacting customers on 04/16/2013. On 04/18/2013, BPV sent a Customer Recall notification Letter via FedEx with proof of delivery notice. The letter included reason for recall, a table of affected product code and lot numbers, instructions (Do not use or further distribute any affected product), a response form (titled Recall and Effectiveness Check Form) enclosed, and contact information.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution: USA Nationwide and Internationally to Europe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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